Symptoms of Stevens-Johnson Syndrome

What is Stevens-Johnson Syndrome?

Stevens-Johnson Syndrome (SJS) is an uncommon but painful skin condition which can result in severe burn-like symptoms and possibly even death. With SJS, the skin blisters and the top layer of affected skin eventually sheds off. The painful blisters spread to mucus membranes throughout the body. SJS can be caused by an adverse reaction to a medication, often from an overdosing or misdosing of medication.

What Are the Symptoms of Stevens-Johnson Syndrome?

When SJS is caused by an adverse reaction to a medication, symptoms typically appear one to three weeks after the person started taking the medication.

1-3 Days Before the Rash Develops

Before the rash develops, patients typically experience flu-like symptoms that include:

  • Sore throat and mouth
  • Fatigue
  • Burning eyes
  • Body aches
  • Cough

 After Flu-Like Symptoms:

Once the flu symptoms have occurred, unexplained and widespread skin pain usually develops. After this occurs, a red or purple-colored rash begins to spread throughout the body. The rash is followed by blisters appearing on the skin—usually starting on the face and chest. The blisters soon spread to the body’s other mucus membranes in the throat, eyes, digestive tract, genitals, and anus.

Symptoms of Mucus Membrane Involvement:

Early symptoms of blisters spreading to mucus membranes throughout the body include light sensitivity, itching or burning of the eyes, and pain when swallowing. Mouth and throat injuries, including painful blisters, trouble swallowing, and breathing, can also manifest.

Eye Symptoms

As the condition progresses, eye symptoms may occur such as:

  • Severe conjunctivitis
  • Discharge
  • Iritis
  • Corneal blisters

The eye damage may become long-term, possibly leading to vision loss.

Genital Symptoms

The genitals may also be impacted by the blisters, with symptoms such as:

  • Inflammation of the urethra
  • Vaginitis
  • Painful blisters
  • Difficulty urinating

Gastrointestinal Symptoms

  • Diarrhea
  • Black or tarry stools
  • Other complications

How Long Do Stevens-Johnson Syndrome Symptoms Last?

SJS symptoms usually continue for about two weeks before the skin and mucus membranes begin to heal themselves. However, it may take many weeks or even months to fully recover. During this time, the remaining attacked skin may peel and fall off before beginning to heal. As the skin heals, it begins to regrow. However, it may grow back unevenly in color and scarring may occur in addition to permanent issues with the eyes and organs.

Serious Complications of Stevens-Johnson Syndrome

Some serious complications from SJS include:

  • Dehydration in areas where the skin has shed is common. This is in addition to bodily dehydration caused by blisters in the mouth and throat that make fluid consumption painful.
  • Blood infection (sepsis) can occur when bacteria from an infection enters the bloodstream and spreads throughout the body. Sepsis can cause shock and multiple organ failure, which may result in death.
  • Meningitis–an infection of the membrane and fluid surrounding the brain and spinal cord.
  • Eye problems can result from the rash caused by SJS and lead to eye inflammation, dry eye, and light sensitivity. In more severe cases, the rash may lead to visual impairment and potentially blindness.
  • Respiratory failure.
  • Permanent skin damage may occur after skin grows back, potentially resulting in bumps, discoloration, scars, hair loss, and abnormal growth of fingernails and toenails.

Can Stevens-Johnson Syndrome Be Fatal?

The most serious complication of SJS is death. Mortality from SJS cases is determined primarily by the extent of skin sloughing (the process of shedding dead surface cells from the skin). When the body surface area (BSA) impacted is less than 10%, the morality rate is approximately 1-5%. However, when more than 30% BSA sloughing is present, the mortality rate increases to between 25% and 35% and may even rise to as high as 50%. Bacteremia (presence of bacteria in the bloodstream) and sepsis (body’s response to an infection that can damage multiple organ systems) also play a substantial role in mortality in SJS cases.

How GoldenbergLaw Can Help You

Our team of Minnesota Stevens-Johnson Syndrome lawyers has the experience and expertise needed to bring a complex medical malpractice claim on behalf of someone diagnosed with SJS. We have over 30 years of experience holding negligent medical providers accountable. Contact us today for a free consultation. Leave the sleepless nights to us.

What Medications Cause Stevens-Johnson Syndrome?

What Is SJS And What Are The Symptoms?

Stevens-Johnson Syndrome (SJS) is a serious and potentially life-threatening skin reaction. SJS reactions typically start with flu-like symptoms and often a rash in which skin blisters like a burn and the top layer of affected skin sheds. The blisters are immensely painful and usually spread throughout the body. As the skin peels off, most people must be hospitalized and are transferred to a burn unit—sometimes for weeks. This may result in permanent impairment to bodily openings such as injuries to the eyes, tear ducts, reproductive organs or anus.

SJS is most commonly caused by the body’s adverse reaction to a medication or an infection. Most medication reactions occur in the first 2-6 weeks of taking the drug.

What Types of Medications Can Cause SJS?

  • Antibacterial sulfa drugs
  • Anti-epileptic drugs, anticonvulsants, antipsychotics
  • Gout and kidney stone treatments
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Antibiotics
  • Antibacterial sulfonamides
  • HIV/AIDS treatment drugs
  • Pain relievers

Specific Medications That Can Cause SJS

  • Allopurinol
  • Carbamazepine
  • Lamotrogine/Lamictal
  • Nevirapine
  • Meloxican and Piroxicam
  • Phenobarbital
  • Phenytoin
  • Sulfa antibiotics
  • Sertraline
  • Sulfasalazine

Black Box Warning On Lamictal/Lamotrogine

A black box warning is the most serious warning the FDA requires to be placed on a medication about its side effects and there is a black box warning on Lamictal. It is a warning to doctors and pharmacists that the risk of developing SJS should be disclosed to the patient. The patient must also be told that at the first signs of developing flu-like symptoms or a rash, they should contact their doctor. This is so the medication may immediately be discontinued and the risks of developing SJS may be minimized.

Lamictal (lamotrigine) is a highly-prescribed anti-epileptic medication known as an anticonvulsant that is most commonly used to treat epileptic seizures in adults or children. The drug is also frequently used to delay mood episodes in patients with bipolar depression (manic depression). It is available as an immediate-release drug and an extended-release Lamictal XR which is only available for use in patients above the age of 13. Children are more vulnerable than adults to develop SJS from using this medication.

Pharmacy Times reported that the black box warning on Lamictal warning of the risk of SJS is one of the top ten black box warnings medical authorities and pharmacies should be aware of when prescribing and/or dispensing such medication due to the life-threatening nature of SJS.

How Can a Doctor Or Pharmacist Contribute to Causing SJS? 

The risk of developing a horrible side effect such as SJS from a medication must be taken into consideration by medical professionals and pharmacists when they prescribe and dispense a medication that has been linked to causing SJS. It is critical that patients are made aware of the risks of taking the medication so they can make an informed, consensual decision to take the medication.

Here are two common mistakes doctors or pharmacists make that can contribute to SJS:

  1. The mistake of prescribing too much medication too quickly. The manufacturer warns that prescribing or dispensing medication linked to SJS in excess of the recommended initial dose or subsequently rapidly accelerating the dosage puts their patients at an increased risk of developing SJS. Such excessive prescriptions also have the ability to elevate the severity of the illness if it develops.
  2. The mistake of failing to advise the patient of the risks of SJS. Despite the well-known links between certain medications and the development of SJS, medical authorities or pharmacists are often unaware of the risks and/or fail to communicate this information to their patients. This may lead to the patient continuing to take the medication despite the early signs of SJS. This is an avoidable oversight that can cause potentially life-threatening harm to patients.

 A Brief Pathology Of How Medications Cause SJS 

Essentially, medication-induced SJS can be caused from a response by a person’s immune system to something that it believes is toxic.

Although there is not yet a consensus in the scientific community about exactly what happens in the body as a person develops SJS, one theory suggests that the cutaneous (skin) reactions account for the majority of the effects after an idiosyncratic reaction (adverse reactions that develop mostly unpredictably) to a medication has occurred. The severe skin issues associated with SJS are also believed to be caused by keratinocyte apoptosis. Keratinocyte apoptosis regulates new skin cells and, in certain circumstances, can result in the body eliminating its own cells. However, an unnecessary elimination of the body’s cells may occur if the keratinocyte apoptosis process becomes dysfunctional–as is the case with SJS–resulting in the damage and elimination of too many cells. This may lead to a cell-mediated cytotoxic (immune) reaction which results in proteins called cytokines being produced and further damage is done to the cells.

How GoldenbergLaw Can Help You

If you, or a loved one, has been diagnosed with Stevens-Johnson Syndrome while taking a medication listed above, you may have a case against the clinic or pharmacy due to a failure to warn or wrongful dosing of the medication. Contact the Stevens-Johnson Syndrome attorneys at GoldenbergLaw today for a free consultation. We understand the devastating effects of SJS. Our team of Stevens-Johnson Syndrome lawyers have the experience and expertise needed to bring a complex malpractice claim. We have over 30+ years of experience holding negligent medical providers accountable. Leave the sleepless nights to us.

The FDA Issues Guidance Addressing Drug Impurities

Why is the FDA Issuing Recommendations?

The U.S. Food and Drug Administration (FDA) issued guidance in September 2020 to help drug manufacturers prevent against unacceptable levels of nitrosamine impurities. These impurities have been linked to cancer and have been found in any popular drugs, including the blood pressure drug Valsartan, the diabetes drug Metformin, and the heartburn drugs Zantac and Ranitidine. The nitrosamine impurity N-nitrosodimethylamine (NDMA) found in each of these medications has been classified as a probable human carcinogen.

Nitrosamine compounds are potent genotoxic agents that are classified as probable or possible human carcinogens by the International Agency for Research on Cancer (IARC).

The FDA has identified 7 nitrosamine impurities that could be present in drug products, including NDMA, NDEA, NMBA, NIPEA, NDIPA, NDBA, AND NMPA. NDMA, NDEA, NMBA, NIPEA and NMPA have already been detected in drug substances or products.

The FDA guidance recommends “a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drug.”

How Are Nitrosamines Contaminating Medications?

The FDA guidance stated potential causes for the presence of nitrosamine impurities in active pharmaceutical ingredients (APIs). The formation of nitrosamines is possible in the presence of secondary, tertiary, or quaternary amines and nitrite salts under acidic reaction conditions. When these conditions occur, nitrite salts may form nitrous acid, which can react with an amine to form a nitrosamine. A greater risk of nitrosamine forming occurs if nitrous acid is used to quench residual azide (a reagent) when precursor amines are present.

Amines may appear during the manufacturing process for a multitude of reasons, such as:

  • API (or API degradants), intermediates, or starting materials may contain secondary or tertiary amine functional groups.
  • Tertiary and quaternary amines may also be added intentionally as reagents or catalysts.
  • The amines may react with nitrous acid or other nitrosating agents to form nitrosamines.

Nitrosamine impurities may also be introduced through the contamination of vendor-sourced materials, including raw materials. The FDA suspects that the contamination can arise through:

  • Fresh solvents being contaminated during shipment from vendors
  • Sodium nitrite (a known impurity in some starting materials) being present and reacting with amines under acidic conditions and form nitrosamines. Nitrate-containing raw materials, such as potassium nitrate, may contain nitrite impurities
  • Secondary or tertiary amines (impurities) that have been reported in some raw materials and solvents such as toluene
  • Starting materials or outsourced intermediate materials that could be at risk through cross-contamination if they are manufactured at locations where nitrosamine impurities are produced in other processes

In response to these concerns, the FDA recommended that manufacturers consider potential causes of nitrosamine formation and prioritize the evaluation of APIs and drug products based on factors such as maximum daily dose, duration of treatment, therapeutic indication, and the number of patients treated.

What is the Government’s Response to the Drug Impurities?

The U.S. Department of Justice (DOJ) and the U.S. Attorney’s Office for the Eastern District of Pennsylvania opened an investigation into whether drug manufacturers such as Sanofi SA previously knew about dangerous levels of NDMA contamination found in the popular heartburn drug Zantac and its generic equivalent, ranitidine. The probe is also investigating whether the manufacturers failed to disclose this information to the federal government.

In July 2020, Sanofi and GlaxoSmithKline (GSK) released Securities and Exchange Commission (SEC) filings stating that they received civil investigative demands from the DOJ in June 2020 requesting information on Zantac. GSK stated, “On 18 June 2020, the Group received a Civil Investigative Demand (CID) from the US Department of Justice (DOJ) seeking information related to Zantac pursuant to the False Claims Act…The Group is co-operating with the DOJ to provide this information. Additionally, on 18 June 2020, the New Mexico Attorney General filed a lawsuit against multiple defendants, including GSK, relating to Zantac and other products containing ranitidine.”

The investigation comes after the FDA set the maximum human daily exposure limit to NDMA at 96 nanograms, but testing by the independent pharmacy Valisure in 2019 revealed more than 3 million nanograms of NDMA in 150mg Zantac pills. Subsequently, the FDA announced a global recall for ranitidine-based medications on April 1, 2020.

How GoldenbergLaw Can Help You

GoldenbergLaw is currently representing clients who have been diagnosed with cancer after taking Zantac or ranitidine products. The Zantac Recall Attorneys at GoldenbergLaw have over 30 years of experience delivering justice to victims of corporate negligence. If you are interested in learning more about a Zantac recall lawsuit, contact us today for a free consultation. Let us deliver the Gold standard advocacy you deserve.